Perspectives in Clinical Research最新文献

{"title":"Bio-entrepreneurs’ bugbear: Regulatory rigmarole","authors":"Arun Bhatt","doi":"10.4103/picr.picr_103_24","DOIUrl":"https://doi.org/10.4103/picr.picr_103_24","url":null,"abstract":"\u0000 Indian biotech startup sector – a rapidly growing business segment focused on the development of innovative products has the potential to make significant contributions to the country’s economy. Indian bio-entrepreneurs’ optimistic expectation of rapidly moving product development from bench to bedside faces tremendous challenges of the complex Indian regulatory system, which is shaped by a diversity of regulatory authorities, rules, guidelines, and processes. This brief review discusses specific regulatory issues faced by bio-entrepreneurs investing in a variety of innovative products – new drugs, vaccines, medical devices, cell, and gene therapy and suggests approaches which can ease Indian entrepreneur’s endeavors.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"222 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141692473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sample size calculation in clinical research","authors":"P. Ranganathan, Vishal Deo, C. Pramesh","doi":"10.4103/picr.picr_100_24","DOIUrl":"https://doi.org/10.4103/picr.picr_100_24","url":null,"abstract":"\u0000 Calculation of sample size is an essential part of research study design since it affects the reliability and feasibility of the research study. In this article, we look at the principles of sample size calculation for different types of research studies.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"40 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141698090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A clinical study to monitor prescription patterns, clinical outcomes, and adverse drug reactions among patients of various interstitial lung diseases attending respiratory medicine outpatient department at tertiary care hospital in Northern India","authors":"Sabahat Hasan, Ajay Verma, Shoebul Haque, Farah Asif, Rajendra Nath, Surya Kant, R. K. Dixit","doi":"10.4103/picr.picr_108_23","DOIUrl":"https://doi.org/10.4103/picr.picr_108_23","url":null,"abstract":"\u0000 \u0000 \u0000 The aim of this study was to monitor prescription patterns, clinical outcomes, and adverse drug reactions (ADR) among patients of various interstitial lung diseases (ILDs).\u0000 \u0000 \u0000 \u0000 This prospective study was conducted in the Department of Pharmacology and Therapeutics in collaboration with the Department of Respiratory Medicine, King George’s Medical University, Lucknow, for a period of 12 months (October 2020–September 2021). A total of 77 patients were enrolled after satisfying the inclusion and exclusion criteria. The prescriptions were collected, and necessary details were noted on the case report form. After completion of the study, the data were analyzed for prescription patterns, clinical outcomes, and quality of life with the help of a validated questionnaire-King’s Brief ILD (KBILD) questionnaire. At the same time, ADRs, if any, were assessed using Hartwig’s Severity Assessment Scale and Naranjo Causality Assessment Scale.\u0000 \u0000 \u0000 \u0000 The most common ILD was acute/chronic hypersensitivity pneumonitis (HP). Average number of drugs per encounter was 4.45. Crepitations were the most common clinical signs. Clubbing and rhonchi were reported maximum in idiopathic pulmonary fibrosis. It was found that psychological, breathlessness and activities, chest symptoms, and total KBILD reduced significantly after 3 months as compared to baseline with a statistically significant difference as P < 0.01. ADRs were found in 23.38% (18) of the subjects. Maximum ADR reported was gastritis (9.09%), followed by hepatitis (3.90%).\u0000 \u0000 \u0000 \u0000 The high proportion of patients clinically diagnosed with HP in our study highlights the importance of a detailed environmental exposure history in the diagnostic evaluation of patients with ILD to avoid inaccurate diagnoses. ADR-related hospital admissions are a significant problem in the health-care system.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"16 23","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141700062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic effectiveness and adverse drug reactions of mirabegron versus solifenacin in the treatment of overactive bladder syndrome","authors":"Megha O. Raj, Jinish Jose, Fredrick Paul, Syam Sreedharan, Nithya Uthaman","doi":"10.4103/picr.picr_166_23","DOIUrl":"https://doi.org/10.4103/picr.picr_166_23","url":null,"abstract":"\u0000 \u0000 \u0000 Overactive bladder (OAB) syndrome is a chronic disease characterized by urinary urgency with or without urge incontinence, frequency, and nocturia and antimuscarinic drugs such as solifenacin have been the mainstay of treatment. Mirabegron a beta 3 adrenoreceptor agonist has recently gained importance in the management of OAB. The rationale of the study is that mirabegron improves the storage function without affecting voiding which increases the therapeutic effectiveness. The objective was to determine the therapeutic effectiveness of mirabegron versus solifenacin.\u0000 \u0000 \u0000 \u0000 A prospective observational study was conducted on 298 patients with OAB syndrome attending the urology outpatient department of government medical college after obtaining institutional review board clearance. Patients of both genders, belonging to the 18–65 years of age group, attending the urology outpatient department were selected for the study. Patients were evaluated using the OAB-validated 8-question awareness tool (OAB-V8 score) before and after receiving drugs by direct questionnaire method after receiving informed consent. Patients were prescribed either solifenacin 5 mg or mirabegron 25 mg once daily by the urologist. Follow-up was done after 4 and 12 weeks. Adverse drug reactions of the drugs were assessed using the Central Drug Standard Control Organization suspected adverse reaction (ADR) form, and ADRs were notified to the nearest ADR monitoring center.\u0000 \u0000 \u0000 \u0000 The mirabegron group showed maximum improvement in the mean OAB-V8 score values from baseline at 4 weeks (12.82 ± 5.86, P < 0.001) and 12 weeks (5.74 ± 3.31, P < 0.001) when compared to solifenacin. OAB-V8 scores of the solifenacin group also showed significant improvement from the baseline at 4 weeks (15.30 ± 5.54, P < 0.001) and 12 weeks (8.05 ± 4.59, P < 0.001). Heart rate, systolic, and diastolic blood pressures did not show significant changes during the follow-up in both the study groups. Thirteen patients developed ADRs such as dry mouth (four patients) and constipation (nine patients) in the solifenacin group. No ADRs were noted in the mirabegron group.\u0000 \u0000 \u0000 \u0000 Mirabegron showed maximum improvement in the OAB-V8 scores in patients with OAB syndrome, although the solifenacin group also showed improvement. Adverse effects were less in the mirabegron group when compared to the solifenacin group.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":" 582","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141127504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Commentary on lack of transparency for Investigators in clinical trials: A bibliometric analysis of literature","authors":"Rohit Prasad","doi":"10.4103/picr.picr_12_24","DOIUrl":"https://doi.org/10.4103/picr.picr_12_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":" 724","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141127556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of informed consent documents for compliance with ICMR guidelines for biomedical and health research","authors":"C. Chindhalore, G. Dakhale, S. Gajbhiye, Ashish Vijay Gupta, Shivam V. Khapeka","doi":"10.4103/picr.picr_257_23","DOIUrl":"https://doi.org/10.4103/picr.picr_257_23","url":null,"abstract":"\u0000 \u0000 \u0000 Ethical conduct of research depends on the voluntary expression of consent and adequate disclosure of information about the research in informed consent documents (ICDs).\u0000 \u0000 \u0000 \u0000 The objective of this study was to analyze ICDs of academic studies for compliance with National Ethical Guidelines for Biomedical and Health Research laid down by the Indian Council of Medical Research (ICMR) and to determine the readability of ICDs using the Flesch–Kincaid Grade Level scale and Flesch reading-ease (FRE) score.\u0000 \u0000 \u0000 \u0000 ICDs of academic research projects submitted during 2020–22 were retrieved from the IEC office and analyzed for compliance with ICMR 2017 guidelines. The readability of the documents was assessed by the Flesch–Kincaid Grade Level Scale and FRE score.\u0000 \u0000 \u0000 \u0000 Among 177 protocols analyzed, the most common were epidemiological studies (36.72%), followed by diagnostic studies (28.81%). Vernacular translations of ICDs were present in significantly more studies in 2022 (χ\u0000 2 = 7.18, P = 0.02) as compared to 2020 and 2021. FREs score was 45.75 ± 10.76, and Flesch–Kincaid Grade Level was 8.67 ± 1.44. Content analysis of participant information sheet (PIS) revealed that significantly more PIS submitted in 2022 mentioned expected duration of participation (χ\u0000 2 = 6.95, P < 0.001), benefit to patient/community (χ\u0000 2 = 26.63, P < 0.001), disclosure of foreseeable risk or discomfort (χ\u0000 2 = 21.72, P < 0.001), payment for participation (χ\u0000 2 = 21.72, P < 0.001), and identity of research team and contact details (χ\u0000 2 = 18.58, P < 0.001). Compliance score was significantly better in 2022 as compared to 2020 and 2021.\u0000 \u0000 \u0000 \u0000 Gradually, ICDs became more compliant with ICMR guidelines. Still, there is scope for improvement in ICDs regarding content and readability so that patients can comprehend facts easily to make informed decisions in a real sense.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"49 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140731998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating large language models for selection of statistical test for research: A pilot study","authors":"Himel Mondal, Shaikat Mondal, Prabhat Mittal","doi":"10.4103/picr.picr_275_23","DOIUrl":"https://doi.org/10.4103/picr.picr_275_23","url":null,"abstract":"\u0000 \u0000 \u0000 In contemporary research, selecting the appropriate statistical test is a critical and often challenging step. The emergence of large language models (LLMs) has offered a promising avenue for automating this process, potentially enhancing the efficiency and accuracy of statistical test selection.\u0000 \u0000 \u0000 \u0000 This study aimed to assess the capability of freely available LLMs – OpenAI’s ChatGPT3.5, Google Bard, Microsoft Bing Chat, and Perplexity in recommending suitable statistical tests for research, comparing their recommendations with those made by human experts.\u0000 \u0000 \u0000 \u0000 A total of 27 case vignettes were prepared for common research models with a question asking suitable statistical tests. The cases were formulated from previously published literature and reviewed by a human expert for their accuracy of information. The LLMs were asked the question with the case vignettes and the process was repeated with paraphrased cases. The concordance (if exactly matching the answer key) and acceptance (when not exactly matching with answer key, but can be considered suitable) were evaluated between LLM’s recommendations and those of human experts.\u0000 \u0000 \u0000 \u0000 Among the 27 case vignettes, ChatGPT3.5-suggested statistical test had 85.19% concordance and 100% acceptance; Bard experiment had 77.78% concordance and 96.3% acceptance; Microsoft Bing Chat had 96.3% concordance and 100% acceptance; and Perplexity had 85.19% concordance and 100% acceptance. The intra-class correction coefficient of average measure among the responses of LLMs was 0.728 (95% confidence interval [CI]: 0.51–0.86), P < 0.0001. The test–retest reliability of ChatGPT was r = 0.71 (95% CI: 0.44–0.86), P < 0.0001, Bard was r = −0.22 (95% CI: −0.56–0.18), P = 0.26, Bing was r = −0.06 (95% CI: −0.44–0.33), P = 0.73, and Perplexity was r = 0.52 (95% CI: 0.16–0.75), P = 0.0059.\u0000 \u0000 \u0000 \u0000 The LLMs, namely, ChatGPT, Google Bard, Microsoft Bing, and Perplexity all showed >75% concordance in suggesting statistical tests for research case vignettes with all having acceptance of >95%. The LLMs had a moderate level of agreement among them. While not a complete replacement for human expertise, these models can serve as effective decision support systems, especially in scenarios where rapid test selection is essential.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"83 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140729191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ethics committee accreditation: Journey from voluntariness to essentiality for quality sustenance","authors":"R. Tripathi","doi":"10.4103/picr.picr_45_24","DOIUrl":"https://doi.org/10.4103/picr.picr_45_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"33 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140762004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness and safety of regimen containing bedaquiline and delamanid in patients with drug-resistant tuberculosis.","authors":"Oki Nugraha Putra, Yulistiani Yulistiani, Soedarsono Soedarsono, Susi Subay","doi":"10.4103/picr.picr_1_23","DOIUrl":"10.4103/picr.picr_1_23","url":null,"abstract":"<p><strong>Background: </strong>Bedaquiline and delamanid have been included in the individualized treatment regimen (ITR) to treat patients with drug-resistant tuberculosis (DR-TB).</p><p><strong>Objective: </strong>The objective of this study is to compare the effectiveness of sputum culture conversion and the safety of ITR containing bedaquiline and delamanid.</p><p><strong>Methods: </strong>Data were collected retrospectively from medical records of DR-TB patients who received ITR between January 2020 and December 2021. Patients were divided into bedaquiline and bedaquiline-delamanid groups. Sputum culture was evaluated until 6 months of treatment. Measurement of QTc interval, renal and liver function test, and serum potassium were evaluated to assess safety during the study period. We used Chi-square to analyze a difference in cumulative culture conversion; meanwhile, Wilcoxon and Mann-Whitney tests were used to analyze differences in laboratory data for each and between the two groups, respectively.</p><p><strong>Results: </strong>Fifty-one eligible DR-TB patients met the inclusion criteria, 41 in the bedaquiline and 10 in bedaquiline-delamanid group. 43/51 patients had a positive culture at baseline. After 6 months of treatment, 42/43 DR-TB patients (97.6%) had sputum culture conversion and no difference between the two groups (<i>P</i> ≥ 0.05). QTc interval within normal limit and no patient had a QTc >500 ms during the study period. Creatinine levels significantly differed between the two groups 6 months after treatment (<i>P</i> < 0.05).</p><p><strong>Conclusion: </strong>DR-TB patients who received all oral ITR containing bedaquiline and or delamanid demonstrated favorable sputum conversion with a tolerable safety profile.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 2","pages":"89-93"},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11101004/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141066027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of accreditation on registered ethics committees in terms of quality and governance in India: A cross-sectional study","authors":"G. Dakhale, M. Kalikar, A. Giradkar","doi":"10.4103/picr.picr_153_23","DOIUrl":"https://doi.org/10.4103/picr.picr_153_23","url":null,"abstract":"\u0000 \u0000 \u0000 Ethics Committee accreditation is a process to assess the performance against a set of standards. Very few studies have shown that process of accreditation results in the improvement of the overall functioning of ECs. in terms of quality and governance. Hence, the present study was planned to evaluate the impact of accreditation on registered EC in terms of quality and governance and to compare functioning of accredited versus non accredited EC in terms of quality and governance.\u0000 \u0000 \u0000 \u0000 This was a cross sectional, observational, questionnaire-based survey conducted on 28 registered Ethics Committee in India after approval from the Institutional Ethics Committee.\u0000 \u0000 \u0000 \u0000 Accredited EC’s (n = 12) were compared for NABH standard for accreditation before and after accreditation in terms of percentage. It was found that majority of the standards related to structure and composition, adherence to specific policies , completeness of review and after approval process were met by majority of EC’s after accreditation. Only a few EC ‘s fulfilled some of the criteria before accreditation. There was a statistically significant difference with reference to adherence to specific policies by accredited and non-accredited EC’s like updating SOP according to changing requirements (P < 0.0237), process for preparing SOP (P < 0.0237), categorization of review process mentioned in SOP (P < 0.0237) procedure to be followed for vulnerable population (P < 0.0103) , process of handling issues related to complaints by participants and other stakeholders violation (P < 0.0103) etc.\u0000 \u0000 \u0000 \u0000 Accreditation results in improving of EC functioning in terms of quality and governance.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"129 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140778012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}